Arkansas Medicaid: A Model of Innovation?

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Arkansas’s Medicaid program is getting noticed.

Earlier this summer, the state  launched a new gainsharing initiative aimed at improving the efficiencies of medicine by keeping down costs for five high-volume episodes of care while still meeting quality standards.

The episodes of care are perinatal care, attention deficit/hyperactivity disorder, upper respiratory infection, hip and knee replacement, and heart failure.

If providers in the program succeed in saving money, they will pocket a percentage of those funds. If they don’t, they’ll need to return some of the excess fees.

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    Staking its territory, the Natural State may become a model for Medicaid reform.

As the New York Times blogger Ezekiel J. Emanuel points out, while such strategies have been tested on a small scale, “this change will now be made in every corner of the state, for every hospital, and physicians in almost every specialty: surgeons, anesthesiologists, obstetricians, pediatricians, primary care physicians. For policy makers and the public, the Arkansas experiment is fascinating.

“If Arkansas succeeds — even partly — it will show the way for the rest of the country,” he wrote.



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Arkansas’s Medicaid program is getting noticed.

Earlier this summer, the state  launched a new gainsharing initiative aimed at improving the efficiencies of medicine by keeping down costs for five high-volume episodes of care while still meeting quality standards.

The episodes of care are perinatal care, attention deficit/hyperactivity disorder, upper respiratory infection, hip and knee replacement, and heart failure.

If providers in the program succeed in saving money, they will pocket a percentage of those funds. If they don’t, they’ll need to return some of the excess fees.

Wikimedia Common
    Staking its territory, the Natural State may become a model for Medicaid reform.

As the New York Times blogger Ezekiel J. Emanuel points out, while such strategies have been tested on a small scale, “this change will now be made in every corner of the state, for every hospital, and physicians in almost every specialty: surgeons, anesthesiologists, obstetricians, pediatricians, primary care physicians. For policy makers and the public, the Arkansas experiment is fascinating.

“If Arkansas succeeds — even partly — it will show the way for the rest of the country,” he wrote.



Arkansas’s Medicaid program is getting noticed.

Earlier this summer, the state  launched a new gainsharing initiative aimed at improving the efficiencies of medicine by keeping down costs for five high-volume episodes of care while still meeting quality standards.

The episodes of care are perinatal care, attention deficit/hyperactivity disorder, upper respiratory infection, hip and knee replacement, and heart failure.

If providers in the program succeed in saving money, they will pocket a percentage of those funds. If they don’t, they’ll need to return some of the excess fees.

Wikimedia Common
    Staking its territory, the Natural State may become a model for Medicaid reform.

As the New York Times blogger Ezekiel J. Emanuel points out, while such strategies have been tested on a small scale, “this change will now be made in every corner of the state, for every hospital, and physicians in almost every specialty: surgeons, anesthesiologists, obstetricians, pediatricians, primary care physicians. For policy makers and the public, the Arkansas experiment is fascinating.

“If Arkansas succeeds — even partly — it will show the way for the rest of the country,” he wrote.



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Musculoskeletal Issues in Diabetics Are a Red Flag

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Musculoskeletal Issues in Diabetics Are a Red Flag

Diabetic patients had a significantly greater prevalence of upper limb musculo-skeletal abnormalities, compared with patients without the disorder, according to a study.

The presence of musculoskeletal abnormalities among diabetic patients also was associated with poor glycemic control.

Diabetic patients who have musculoskeletal abnormalities should have their glycemic control thoroughly assessed and should be examined for other complications, wrote the study's lead author, Dr. Navdha Ramchurn, from the department of rheumatology at the Gateshead (England) Health NHS Foundation Trust.

Dr. Ramchurn and his colleagues compared 96 patients with type 1 and 2 diabetes (mean age 55 years; 63% male) who were seeking care at the Gateshead Diabetes Center with 100 age- and gender-matched controls who were medical outpatients without diabetes. All patients were screened for musculoskeletal abnormalities using the GALS (gait, arms, legs, spine) instrument and the Regional Examination of the Musculoskeletal System (REMS).

About 75% of the diabetic patients screened positive for on the GALS, compared with 53% of the controls (Eur. J. Intern. Med. 2009 [doi:10. 1016/j.ejim.2009.08.00].

Mean hemoglobin A1c values were significantly higher among diabetic patients with hand and shoulder abnormalities, compared with those who had no abnormalities (9.1 vs. 8.0).

The investigators did not have any financial conflicts of interest.

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Diabetic patients had a significantly greater prevalence of upper limb musculo-skeletal abnormalities, compared with patients without the disorder, according to a study.

The presence of musculoskeletal abnormalities among diabetic patients also was associated with poor glycemic control.

Diabetic patients who have musculoskeletal abnormalities should have their glycemic control thoroughly assessed and should be examined for other complications, wrote the study's lead author, Dr. Navdha Ramchurn, from the department of rheumatology at the Gateshead (England) Health NHS Foundation Trust.

Dr. Ramchurn and his colleagues compared 96 patients with type 1 and 2 diabetes (mean age 55 years; 63% male) who were seeking care at the Gateshead Diabetes Center with 100 age- and gender-matched controls who were medical outpatients without diabetes. All patients were screened for musculoskeletal abnormalities using the GALS (gait, arms, legs, spine) instrument and the Regional Examination of the Musculoskeletal System (REMS).

About 75% of the diabetic patients screened positive for on the GALS, compared with 53% of the controls (Eur. J. Intern. Med. 2009 [doi:10. 1016/j.ejim.2009.08.00].

Mean hemoglobin A1c values were significantly higher among diabetic patients with hand and shoulder abnormalities, compared with those who had no abnormalities (9.1 vs. 8.0).

The investigators did not have any financial conflicts of interest.

Diabetic patients had a significantly greater prevalence of upper limb musculo-skeletal abnormalities, compared with patients without the disorder, according to a study.

The presence of musculoskeletal abnormalities among diabetic patients also was associated with poor glycemic control.

Diabetic patients who have musculoskeletal abnormalities should have their glycemic control thoroughly assessed and should be examined for other complications, wrote the study's lead author, Dr. Navdha Ramchurn, from the department of rheumatology at the Gateshead (England) Health NHS Foundation Trust.

Dr. Ramchurn and his colleagues compared 96 patients with type 1 and 2 diabetes (mean age 55 years; 63% male) who were seeking care at the Gateshead Diabetes Center with 100 age- and gender-matched controls who were medical outpatients without diabetes. All patients were screened for musculoskeletal abnormalities using the GALS (gait, arms, legs, spine) instrument and the Regional Examination of the Musculoskeletal System (REMS).

About 75% of the diabetic patients screened positive for on the GALS, compared with 53% of the controls (Eur. J. Intern. Med. 2009 [doi:10. 1016/j.ejim.2009.08.00].

Mean hemoglobin A1c values were significantly higher among diabetic patients with hand and shoulder abnormalities, compared with those who had no abnormalities (9.1 vs. 8.0).

The investigators did not have any financial conflicts of interest.

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16% of Health Staff Wouldn't Work in Pandemic

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16% of Health Staff Wouldn't Work in Pandemic

About one in six surveyed public health workers said they would not report to work in the event of an influenza pandemic emergency, according to an online survey of more than 1,800 public health employees in Minnesota, Ohio, and West Virginia.

Overall, 16% of the health workers said that they were unwilling to “respond to a pandemic flu emergency regardless of its severity,” according to the findings of the survey, which was conducted from November 2006 to December 2007.

Still, that represents an improvement over the 40% of public health employees who in 2005 said they would be unlikely to report to work under the same pandemic circumstances, according to the researcher team that conducted both surveys (PLoS One 2009 July 24;4:e6365).

Responses from the 1,835 public health employees in the current survey were analyzed using the extended parallel process model, which describes an individual's willingness to follow instructions in an emergency, given that person's perception of a threat and his or her belief in the ability to have a positive impact on the outcome.

Individuals who had a perception of high threat and high efficacy were nearly 32 times more likely to say that they would be willing to report to work during a flu pandemic, compared with individuals who reported a low threat and low efficacy perception.

“These results … reveal a unique opportunity to induce change,” according to the researchers. “The first step is to better educate public heath workers as to their designed roles during this emergency scenario, and then motivate them with an understanding of why this role makes a difference.”

“Employee response is a critical component of preparedness planning, yet it is often overlooked. Our study is an attempt to understand the underlying factors that determine an employee's willingness to respond in an emergency,” said the study's lead investigator, Dr. Daniel Barnett, of the department of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The study was funded by the CDC's Centers for Public Health Preparedness program, and by the CDC's Preparedness and Emergency Response Research Centers program.

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About one in six surveyed public health workers said they would not report to work in the event of an influenza pandemic emergency, according to an online survey of more than 1,800 public health employees in Minnesota, Ohio, and West Virginia.

Overall, 16% of the health workers said that they were unwilling to “respond to a pandemic flu emergency regardless of its severity,” according to the findings of the survey, which was conducted from November 2006 to December 2007.

Still, that represents an improvement over the 40% of public health employees who in 2005 said they would be unlikely to report to work under the same pandemic circumstances, according to the researcher team that conducted both surveys (PLoS One 2009 July 24;4:e6365).

Responses from the 1,835 public health employees in the current survey were analyzed using the extended parallel process model, which describes an individual's willingness to follow instructions in an emergency, given that person's perception of a threat and his or her belief in the ability to have a positive impact on the outcome.

Individuals who had a perception of high threat and high efficacy were nearly 32 times more likely to say that they would be willing to report to work during a flu pandemic, compared with individuals who reported a low threat and low efficacy perception.

“These results … reveal a unique opportunity to induce change,” according to the researchers. “The first step is to better educate public heath workers as to their designed roles during this emergency scenario, and then motivate them with an understanding of why this role makes a difference.”

“Employee response is a critical component of preparedness planning, yet it is often overlooked. Our study is an attempt to understand the underlying factors that determine an employee's willingness to respond in an emergency,” said the study's lead investigator, Dr. Daniel Barnett, of the department of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The study was funded by the CDC's Centers for Public Health Preparedness program, and by the CDC's Preparedness and Emergency Response Research Centers program.

About one in six surveyed public health workers said they would not report to work in the event of an influenza pandemic emergency, according to an online survey of more than 1,800 public health employees in Minnesota, Ohio, and West Virginia.

Overall, 16% of the health workers said that they were unwilling to “respond to a pandemic flu emergency regardless of its severity,” according to the findings of the survey, which was conducted from November 2006 to December 2007.

Still, that represents an improvement over the 40% of public health employees who in 2005 said they would be unlikely to report to work under the same pandemic circumstances, according to the researcher team that conducted both surveys (PLoS One 2009 July 24;4:e6365).

Responses from the 1,835 public health employees in the current survey were analyzed using the extended parallel process model, which describes an individual's willingness to follow instructions in an emergency, given that person's perception of a threat and his or her belief in the ability to have a positive impact on the outcome.

Individuals who had a perception of high threat and high efficacy were nearly 32 times more likely to say that they would be willing to report to work during a flu pandemic, compared with individuals who reported a low threat and low efficacy perception.

“These results … reveal a unique opportunity to induce change,” according to the researchers. “The first step is to better educate public heath workers as to their designed roles during this emergency scenario, and then motivate them with an understanding of why this role makes a difference.”

“Employee response is a critical component of preparedness planning, yet it is often overlooked. Our study is an attempt to understand the underlying factors that determine an employee's willingness to respond in an emergency,” said the study's lead investigator, Dr. Daniel Barnett, of the department of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The study was funded by the CDC's Centers for Public Health Preparedness program, and by the CDC's Preparedness and Emergency Response Research Centers program.

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Some in Public Health Wary of Pandemic Duty : Some 16% were unwilling to respond to a pandemic flu emergency no matter what.

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Some in Public Health Wary of Pandemic Duty : Some 16% were unwilling to respond to a pandemic flu emergency no matter what.

About one in six surveyed public health workers said they would not report to work in the event of an influenza pandemic emergency, according to an survey of more than 1,800 public health employees in Minnesota, Ohio, and West Virginia that was conducted online.

Overall, 16% of the health workers said they were unwilling to “respond to a pandemic flu emergency regardless of its severity,” according to the findings of the survey, which was conducted from November 2006 to December 2007.

Nonetheless, that represents an improvement over the 40% of public health employees who in 2005 said they would be unlikely to report to work under the same pandemic circumstances, according to the researcher team that conducted both surveys. The current survey findings were published in the July 24 issue of the journal PLoS one.

Responses from the 1,835 public health employees in the current survey were analyzed using the Extended Parallel Process Model, which describes an individual's willingness to follow instructions in an emergency, given that person's perception of a threat and his or her belief in the ability to have a positive impact on the threat (PLoS One 2009;4:e6365).

Individuals who had a perception of high threat and high efficacy were nearly 32 times more likely to say they would be willing to report to work during a flu pandemic, compared with those who reported a low threat and low efficacy perception.

“These results … reveal a unique opportunity to induce change,” according to the researchers.

“The first step is to better educate public heath workers as to their designed roles during this emergency scenario, and then motivate them with an understanding of why this role makes a difference,” they continued.

“Employee response is a critical component of preparedness planning, yet it is often overlooked.

“Our study is an attempt to understand the underlying factors that determine an employee's willingness to respond in an emergency,” said the study's lead investigator, Dr. Daniel Barnett, assistant professor in the department of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The study was funded by the Centers for Disease Control and Prevention's Centers for Public Health Preparedness Program, and by the CDC's Preparedness and Emergency Response Research Centers program.

The authors of the study reported having no conflicts of interest.

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About one in six surveyed public health workers said they would not report to work in the event of an influenza pandemic emergency, according to an survey of more than 1,800 public health employees in Minnesota, Ohio, and West Virginia that was conducted online.

Overall, 16% of the health workers said they were unwilling to “respond to a pandemic flu emergency regardless of its severity,” according to the findings of the survey, which was conducted from November 2006 to December 2007.

Nonetheless, that represents an improvement over the 40% of public health employees who in 2005 said they would be unlikely to report to work under the same pandemic circumstances, according to the researcher team that conducted both surveys. The current survey findings were published in the July 24 issue of the journal PLoS one.

Responses from the 1,835 public health employees in the current survey were analyzed using the Extended Parallel Process Model, which describes an individual's willingness to follow instructions in an emergency, given that person's perception of a threat and his or her belief in the ability to have a positive impact on the threat (PLoS One 2009;4:e6365).

Individuals who had a perception of high threat and high efficacy were nearly 32 times more likely to say they would be willing to report to work during a flu pandemic, compared with those who reported a low threat and low efficacy perception.

“These results … reveal a unique opportunity to induce change,” according to the researchers.

“The first step is to better educate public heath workers as to their designed roles during this emergency scenario, and then motivate them with an understanding of why this role makes a difference,” they continued.

“Employee response is a critical component of preparedness planning, yet it is often overlooked.

“Our study is an attempt to understand the underlying factors that determine an employee's willingness to respond in an emergency,” said the study's lead investigator, Dr. Daniel Barnett, assistant professor in the department of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The study was funded by the Centers for Disease Control and Prevention's Centers for Public Health Preparedness Program, and by the CDC's Preparedness and Emergency Response Research Centers program.

The authors of the study reported having no conflicts of interest.

About one in six surveyed public health workers said they would not report to work in the event of an influenza pandemic emergency, according to an survey of more than 1,800 public health employees in Minnesota, Ohio, and West Virginia that was conducted online.

Overall, 16% of the health workers said they were unwilling to “respond to a pandemic flu emergency regardless of its severity,” according to the findings of the survey, which was conducted from November 2006 to December 2007.

Nonetheless, that represents an improvement over the 40% of public health employees who in 2005 said they would be unlikely to report to work under the same pandemic circumstances, according to the researcher team that conducted both surveys. The current survey findings were published in the July 24 issue of the journal PLoS one.

Responses from the 1,835 public health employees in the current survey were analyzed using the Extended Parallel Process Model, which describes an individual's willingness to follow instructions in an emergency, given that person's perception of a threat and his or her belief in the ability to have a positive impact on the threat (PLoS One 2009;4:e6365).

Individuals who had a perception of high threat and high efficacy were nearly 32 times more likely to say they would be willing to report to work during a flu pandemic, compared with those who reported a low threat and low efficacy perception.

“These results … reveal a unique opportunity to induce change,” according to the researchers.

“The first step is to better educate public heath workers as to their designed roles during this emergency scenario, and then motivate them with an understanding of why this role makes a difference,” they continued.

“Employee response is a critical component of preparedness planning, yet it is often overlooked.

“Our study is an attempt to understand the underlying factors that determine an employee's willingness to respond in an emergency,” said the study's lead investigator, Dr. Daniel Barnett, assistant professor in the department of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The study was funded by the Centers for Disease Control and Prevention's Centers for Public Health Preparedness Program, and by the CDC's Preparedness and Emergency Response Research Centers program.

The authors of the study reported having no conflicts of interest.

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Medical-Legal Partnerships Support Patients' Health

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Medical-Legal Partnerships Support Patients' Health

Dr. Colleen Cagno recalls a patient who urgently needed help renewing his public housing.

She and a lawyer who works down the hall documented how his medical condition qualified him for public housing, and expedited the process to prevent an eviction that would have taken a toll on the patient's health, said Dr. Cagno, associate residency program director in the department of family and community medicine at the University of Arizona, Tucson.

In October 2005, the faculty and residents started offering such services to low-income patients and families under a medical-legal partnership known as the Tucson Family Advocacy Program. Now, two lawyers are available in the teaching clinic for a total of 40 hours per week. Since opening its doors, TFAP has assisted more than 370 patients with more than 770 legal matters affecting health, including disability benefits, Medicaid, Medicare, housing conditions, public benefits, advance directives, and domestic violence.

The program is one of more than 70 medical-legal partnerships operating or soon-to-be operating across the country, explained Anne M. Ryan, J.D., director of TFAP. Across the country, medical-legal partnerships are found in a variety of settings, from universities to legal aid offices, hospitals, and law schools, Ms. Ryan added.

A wealth of literature indicates that “if we don't address our patients' [basic nonmedical] needs, we [as physicians] end up spending more time in other ways,” Dr. Cagno added.

These are the patients who often come in again and again. At first glance, they might appear to have a difficult time complying with their medication regimen, but often at the root of that problem is a social or financial obstacle.

With half of her clinic's patients on Medicaid, Dr. Cagno noted that it's not unusual for them to struggle with basic needs such as housing and food, so paying for medications becomes a second-tier priority.

Patients with asthma have needed legal assistance dealing with landlords who are slow to eradicate a roach or mold infestation problem. Others are living with domestic violence, a situation in which having the clinic's legal and social services on hand makes all the difference.

In another case, a 46-year-old man who was used to living from paycheck to paycheck from his store clerk job worried about providing for his family after he was diagnosed with advanced cancer and was no longer able to work. In conjunction with his physician, TFAP helped him obtain temporary state assistance and expedited Social Security disability benefits, enabling the family to keep its home and car. Without the coordination of medical and legal services, his family would have needed to wait 6 months for disability benefits to begin, Ms. Ryan noted.

“It's providing that kind of patient-centered holistic care that really gets to the concept of the medical home,” Dr. Cagno added.

Funding for TFAP comes from a variety of sources, including the Arizona Foundation for Legal Services and Education, Southern Arizona Legal Aid, the United Way of Tucson and Southern Arizona, and the University of Arizona Foundation. In addition, the university's department of family and community medicine pays for the staff time of the physicians who are involved in the partnership, and the clinic provides the office space for the lawyers, a social worker, and interns.

Physicians practicing outside of academic medicine may lack the backing of such funding sources, Dr. Cagno and Ms. Ryan acknowledged. But they both insist that there are resources out there. To start, every state has legal aid offices, which provide free legal services to individuals with limited income. In addition, there are free legal service providers in every state that help disabled individuals, Ms. Ryan said. And in many communities, lawyers volunteer their services to those in need either pro bono or on a sliding scale.

Physicians frequently get discouraged because they don't have the time to find services for their patients who are in need, Dr. Cagno said. But in every community there are at least one or two key social service providers who will do the digging to help patients find services.

Screening patients for social or financial problems is a good first step, Dr. Cagno and Ms. Ryan agreed. Ms. Ryan suggested asking just a few open-ended questions, such as “Every family has fights. Tell me about fights in your home.” Or “Have you ever cut your medicine dose in half or skipped it because you couldn't afford it?” Many patients do not want to apply for public assistance. The key is to destigmatize the need by having their physicians ask questions that validate their needs, she said.

 

 

Screening by physicians is crucial. Of patients referred to the TFAP last year, 94% had not previously sought legal help for their problems. All, however, had discussed their concerns with their family health care providers.

According to Ms. Ryan, “This statistic supports a fundamental principle of medical-legal partnerships like TFAP: Providing multidisciplinary legal services in a trusted health care setting is an effective way to identify and help people access the benefits and services they need. We believe that lawyers, physicians, social workers, and patients can work together to prevent or overcome many nonmedical problems that impact health.”

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Dr. Colleen Cagno recalls a patient who urgently needed help renewing his public housing.

She and a lawyer who works down the hall documented how his medical condition qualified him for public housing, and expedited the process to prevent an eviction that would have taken a toll on the patient's health, said Dr. Cagno, associate residency program director in the department of family and community medicine at the University of Arizona, Tucson.

In October 2005, the faculty and residents started offering such services to low-income patients and families under a medical-legal partnership known as the Tucson Family Advocacy Program. Now, two lawyers are available in the teaching clinic for a total of 40 hours per week. Since opening its doors, TFAP has assisted more than 370 patients with more than 770 legal matters affecting health, including disability benefits, Medicaid, Medicare, housing conditions, public benefits, advance directives, and domestic violence.

The program is one of more than 70 medical-legal partnerships operating or soon-to-be operating across the country, explained Anne M. Ryan, J.D., director of TFAP. Across the country, medical-legal partnerships are found in a variety of settings, from universities to legal aid offices, hospitals, and law schools, Ms. Ryan added.

A wealth of literature indicates that “if we don't address our patients' [basic nonmedical] needs, we [as physicians] end up spending more time in other ways,” Dr. Cagno added.

These are the patients who often come in again and again. At first glance, they might appear to have a difficult time complying with their medication regimen, but often at the root of that problem is a social or financial obstacle.

With half of her clinic's patients on Medicaid, Dr. Cagno noted that it's not unusual for them to struggle with basic needs such as housing and food, so paying for medications becomes a second-tier priority.

Patients with asthma have needed legal assistance dealing with landlords who are slow to eradicate a roach or mold infestation problem. Others are living with domestic violence, a situation in which having the clinic's legal and social services on hand makes all the difference.

In another case, a 46-year-old man who was used to living from paycheck to paycheck from his store clerk job worried about providing for his family after he was diagnosed with advanced cancer and was no longer able to work. In conjunction with his physician, TFAP helped him obtain temporary state assistance and expedited Social Security disability benefits, enabling the family to keep its home and car. Without the coordination of medical and legal services, his family would have needed to wait 6 months for disability benefits to begin, Ms. Ryan noted.

“It's providing that kind of patient-centered holistic care that really gets to the concept of the medical home,” Dr. Cagno added.

Funding for TFAP comes from a variety of sources, including the Arizona Foundation for Legal Services and Education, Southern Arizona Legal Aid, the United Way of Tucson and Southern Arizona, and the University of Arizona Foundation. In addition, the university's department of family and community medicine pays for the staff time of the physicians who are involved in the partnership, and the clinic provides the office space for the lawyers, a social worker, and interns.

Physicians practicing outside of academic medicine may lack the backing of such funding sources, Dr. Cagno and Ms. Ryan acknowledged. But they both insist that there are resources out there. To start, every state has legal aid offices, which provide free legal services to individuals with limited income. In addition, there are free legal service providers in every state that help disabled individuals, Ms. Ryan said. And in many communities, lawyers volunteer their services to those in need either pro bono or on a sliding scale.

Physicians frequently get discouraged because they don't have the time to find services for their patients who are in need, Dr. Cagno said. But in every community there are at least one or two key social service providers who will do the digging to help patients find services.

Screening patients for social or financial problems is a good first step, Dr. Cagno and Ms. Ryan agreed. Ms. Ryan suggested asking just a few open-ended questions, such as “Every family has fights. Tell me about fights in your home.” Or “Have you ever cut your medicine dose in half or skipped it because you couldn't afford it?” Many patients do not want to apply for public assistance. The key is to destigmatize the need by having their physicians ask questions that validate their needs, she said.

 

 

Screening by physicians is crucial. Of patients referred to the TFAP last year, 94% had not previously sought legal help for their problems. All, however, had discussed their concerns with their family health care providers.

According to Ms. Ryan, “This statistic supports a fundamental principle of medical-legal partnerships like TFAP: Providing multidisciplinary legal services in a trusted health care setting is an effective way to identify and help people access the benefits and services they need. We believe that lawyers, physicians, social workers, and patients can work together to prevent or overcome many nonmedical problems that impact health.”

Dr. Colleen Cagno recalls a patient who urgently needed help renewing his public housing.

She and a lawyer who works down the hall documented how his medical condition qualified him for public housing, and expedited the process to prevent an eviction that would have taken a toll on the patient's health, said Dr. Cagno, associate residency program director in the department of family and community medicine at the University of Arizona, Tucson.

In October 2005, the faculty and residents started offering such services to low-income patients and families under a medical-legal partnership known as the Tucson Family Advocacy Program. Now, two lawyers are available in the teaching clinic for a total of 40 hours per week. Since opening its doors, TFAP has assisted more than 370 patients with more than 770 legal matters affecting health, including disability benefits, Medicaid, Medicare, housing conditions, public benefits, advance directives, and domestic violence.

The program is one of more than 70 medical-legal partnerships operating or soon-to-be operating across the country, explained Anne M. Ryan, J.D., director of TFAP. Across the country, medical-legal partnerships are found in a variety of settings, from universities to legal aid offices, hospitals, and law schools, Ms. Ryan added.

A wealth of literature indicates that “if we don't address our patients' [basic nonmedical] needs, we [as physicians] end up spending more time in other ways,” Dr. Cagno added.

These are the patients who often come in again and again. At first glance, they might appear to have a difficult time complying with their medication regimen, but often at the root of that problem is a social or financial obstacle.

With half of her clinic's patients on Medicaid, Dr. Cagno noted that it's not unusual for them to struggle with basic needs such as housing and food, so paying for medications becomes a second-tier priority.

Patients with asthma have needed legal assistance dealing with landlords who are slow to eradicate a roach or mold infestation problem. Others are living with domestic violence, a situation in which having the clinic's legal and social services on hand makes all the difference.

In another case, a 46-year-old man who was used to living from paycheck to paycheck from his store clerk job worried about providing for his family after he was diagnosed with advanced cancer and was no longer able to work. In conjunction with his physician, TFAP helped him obtain temporary state assistance and expedited Social Security disability benefits, enabling the family to keep its home and car. Without the coordination of medical and legal services, his family would have needed to wait 6 months for disability benefits to begin, Ms. Ryan noted.

“It's providing that kind of patient-centered holistic care that really gets to the concept of the medical home,” Dr. Cagno added.

Funding for TFAP comes from a variety of sources, including the Arizona Foundation for Legal Services and Education, Southern Arizona Legal Aid, the United Way of Tucson and Southern Arizona, and the University of Arizona Foundation. In addition, the university's department of family and community medicine pays for the staff time of the physicians who are involved in the partnership, and the clinic provides the office space for the lawyers, a social worker, and interns.

Physicians practicing outside of academic medicine may lack the backing of such funding sources, Dr. Cagno and Ms. Ryan acknowledged. But they both insist that there are resources out there. To start, every state has legal aid offices, which provide free legal services to individuals with limited income. In addition, there are free legal service providers in every state that help disabled individuals, Ms. Ryan said. And in many communities, lawyers volunteer their services to those in need either pro bono or on a sliding scale.

Physicians frequently get discouraged because they don't have the time to find services for their patients who are in need, Dr. Cagno said. But in every community there are at least one or two key social service providers who will do the digging to help patients find services.

Screening patients for social or financial problems is a good first step, Dr. Cagno and Ms. Ryan agreed. Ms. Ryan suggested asking just a few open-ended questions, such as “Every family has fights. Tell me about fights in your home.” Or “Have you ever cut your medicine dose in half or skipped it because you couldn't afford it?” Many patients do not want to apply for public assistance. The key is to destigmatize the need by having their physicians ask questions that validate their needs, she said.

 

 

Screening by physicians is crucial. Of patients referred to the TFAP last year, 94% had not previously sought legal help for their problems. All, however, had discussed their concerns with their family health care providers.

According to Ms. Ryan, “This statistic supports a fundamental principle of medical-legal partnerships like TFAP: Providing multidisciplinary legal services in a trusted health care setting is an effective way to identify and help people access the benefits and services they need. We believe that lawyers, physicians, social workers, and patients can work together to prevent or overcome many nonmedical problems that impact health.”

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Radio Frequency ID Devices Can Interfere With Equipment

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Radio frequency identification devices for tracking blood products and medical supplies in hospitals demonstrated enough electromagnetic interference with intensive care unit equipment to be potentially hazardous to patients, according to a report in the June 25 issue of JAMA.

The findings are alarming because the application of such radio frequency identification devices (RFIDs) is increasingly being explored in health care settings, Dr. Donald Berwick noted in an accompanying editorial.

The technology, which is used in everything from security access cards to electronic toll-collection devices, is currently under investigation for remotely monitoring medical equipment and for tracking inventory and the placement of specific items such as surgical sponges.

The findings suggest that on-site tests of electromagnetic interference are warranted before hospitals start using new RFIDs, said Dr. Erik Jan van Lieshout, one of the study's coauthors from the University of Amsterdam, and his associates.

The investigators analyzed the effects of two RFIDs on 41 medical equipment systems in simulation studies that did not involve patients. The RFIDs were selected because they were being studied for their usefulness in tracking blood products and expensive medical supplies in the ICU.

Each of the 41 medical equipment systems was subjected to three tests of electromagnetic interference in a one-bed ICU room. Of the 123 tests, 34 induced an electromagnetic interference incident that was reproducible. Of those 32 incidents, 22 were considered potentially hazardous and included the switching off of ventilator equipment, complete stoppage of syringe pumps, and incorrect inhibition of pacemakers (JAMA 2008;299:2884–90).

The RFID that had a passive tag, meaning that it is powered by the electromagnetic field of the reader device, induced a greater number of incidents than did an active tag, in which a power source transmits continuously to the reader. The median distance at which the incidents occurred was 30 cm.

In his editorial, Dr. Berwick took issue with the investigators' disclaimer that their findings apply only to the specific RFID systems they tested.

“Frankly the 2 tested systems are not unlike many others in current use, and attention must be paid to these disturbing findings,” wrote the president and chief executive officer of the Institute for Healthcare Improvement, based in Cambridge, Mass. (JAMA 2008;299:2898–99).

'Attention must be paid to these disturbing findings.' DR. BERWICK

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Radio frequency identification devices for tracking blood products and medical supplies in hospitals demonstrated enough electromagnetic interference with intensive care unit equipment to be potentially hazardous to patients, according to a report in the June 25 issue of JAMA.

The findings are alarming because the application of such radio frequency identification devices (RFIDs) is increasingly being explored in health care settings, Dr. Donald Berwick noted in an accompanying editorial.

The technology, which is used in everything from security access cards to electronic toll-collection devices, is currently under investigation for remotely monitoring medical equipment and for tracking inventory and the placement of specific items such as surgical sponges.

The findings suggest that on-site tests of electromagnetic interference are warranted before hospitals start using new RFIDs, said Dr. Erik Jan van Lieshout, one of the study's coauthors from the University of Amsterdam, and his associates.

The investigators analyzed the effects of two RFIDs on 41 medical equipment systems in simulation studies that did not involve patients. The RFIDs were selected because they were being studied for their usefulness in tracking blood products and expensive medical supplies in the ICU.

Each of the 41 medical equipment systems was subjected to three tests of electromagnetic interference in a one-bed ICU room. Of the 123 tests, 34 induced an electromagnetic interference incident that was reproducible. Of those 32 incidents, 22 were considered potentially hazardous and included the switching off of ventilator equipment, complete stoppage of syringe pumps, and incorrect inhibition of pacemakers (JAMA 2008;299:2884–90).

The RFID that had a passive tag, meaning that it is powered by the electromagnetic field of the reader device, induced a greater number of incidents than did an active tag, in which a power source transmits continuously to the reader. The median distance at which the incidents occurred was 30 cm.

In his editorial, Dr. Berwick took issue with the investigators' disclaimer that their findings apply only to the specific RFID systems they tested.

“Frankly the 2 tested systems are not unlike many others in current use, and attention must be paid to these disturbing findings,” wrote the president and chief executive officer of the Institute for Healthcare Improvement, based in Cambridge, Mass. (JAMA 2008;299:2898–99).

'Attention must be paid to these disturbing findings.' DR. BERWICK

Radio frequency identification devices for tracking blood products and medical supplies in hospitals demonstrated enough electromagnetic interference with intensive care unit equipment to be potentially hazardous to patients, according to a report in the June 25 issue of JAMA.

The findings are alarming because the application of such radio frequency identification devices (RFIDs) is increasingly being explored in health care settings, Dr. Donald Berwick noted in an accompanying editorial.

The technology, which is used in everything from security access cards to electronic toll-collection devices, is currently under investigation for remotely monitoring medical equipment and for tracking inventory and the placement of specific items such as surgical sponges.

The findings suggest that on-site tests of electromagnetic interference are warranted before hospitals start using new RFIDs, said Dr. Erik Jan van Lieshout, one of the study's coauthors from the University of Amsterdam, and his associates.

The investigators analyzed the effects of two RFIDs on 41 medical equipment systems in simulation studies that did not involve patients. The RFIDs were selected because they were being studied for their usefulness in tracking blood products and expensive medical supplies in the ICU.

Each of the 41 medical equipment systems was subjected to three tests of electromagnetic interference in a one-bed ICU room. Of the 123 tests, 34 induced an electromagnetic interference incident that was reproducible. Of those 32 incidents, 22 were considered potentially hazardous and included the switching off of ventilator equipment, complete stoppage of syringe pumps, and incorrect inhibition of pacemakers (JAMA 2008;299:2884–90).

The RFID that had a passive tag, meaning that it is powered by the electromagnetic field of the reader device, induced a greater number of incidents than did an active tag, in which a power source transmits continuously to the reader. The median distance at which the incidents occurred was 30 cm.

In his editorial, Dr. Berwick took issue with the investigators' disclaimer that their findings apply only to the specific RFID systems they tested.

“Frankly the 2 tested systems are not unlike many others in current use, and attention must be paid to these disturbing findings,” wrote the president and chief executive officer of the Institute for Healthcare Improvement, based in Cambridge, Mass. (JAMA 2008;299:2898–99).

'Attention must be paid to these disturbing findings.' DR. BERWICK

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Primary Care Role Urged as Caries Rise in 2- to 5-Year-Olds

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A significant increase in the prevalence rates of dental caries in the primary teeth of children aged 2–5 years has experts urging primary care providers to reevaluate their role in preventing such outcomes.

In 1988–1994, 24% of children aged 2–5 years had dental caries in their primary teeth. By 1999–2004, that rate had edged up to 28%, according to a report from the Centers for Disease Control and Prevention.

The population sample from the CDC's National Center for Health Statistics involved more than 52,000 participants, aged 2–75 years and older. All of the participants had oral health exams, and they or their parents, in the case of children, underwent home interviews. About half of the group was assessed during 1988–1994; the other half was assessed during 1999–2004.

“It's not a surprise at all,” that the dental decay rates are going up among the youngest age set, said Dr. Alan B. Douglass, associate director of the family practice residency program at Middlesex Hospital, in Middletown, Conn. Eighty percent of dental disease clusters in the 20% of children who are at high risk for the disease because they are from low-income families. “It's the access to care issue that's the driver. We are seeing more dental decay because these high-risk kids are having trouble getting access to care.”

In many states, Medicaid reimburses dentists less than the cost of delivering care, which tends to involve high overhead because of the instruments required, Dr. Douglass explained.

Through hearings, such as those in Congress earlier this month, and with several legislative efforts at the state level, advocates hope to achieve parity for dental care under Medicaid.

But until better access is achieved, “It's incumbent upon family physicians to get involved,” Dr. Douglass urged. “They and other primary pediatric care providers are the only medical professionals who are seeing kids when the disease starts,” which in many cases is as soon as teeth start to erupt at 6 to 9 months of age.

Dental disease already has set in by the time a child is 2 years old, by which point “family physicians and other primary pediatric providers have seen these kids at least 7 or 8 times,” noted Dr. Russell Maier, program director of Central Washington Family Medicine Residency in Yakima.

Primary care providers can't treat dental disease once it's there, but they can do a lot to prevent it. At each wellness visit, they need to look at a child's teeth and decide if the individual is in the at-risk group. If the parents' teeth are missing or if they've had a lot of restorative work, that should raise a red flag, Dr. Douglass said.

Primary care providers are critical in raising parental awareness about the importance of oral hygiene, diet, and eating patterns, he added.

Moreover, primary care providers are well placed to address the need for flouride and to advocate on behalf of a high-risk patient to ensure that he or she sees a dentist at age 1 year.

Dr. Douglass admits that, in many cases, such advocacy would require “working the system” to overcome poor access to care—there are only about 5,000 pediatric dentists in the United States—and the difficulties in finding a dentist willing to accept Medicaid patients. (See column above.)

Dental disease is the most common unmet pediatric health care need in this country, and yet at the same time “we know what causes it. We know what we need to do to arrest and prevent its complications,” Dr. Maier said.

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A significant increase in the prevalence rates of dental caries in the primary teeth of children aged 2–5 years has experts urging primary care providers to reevaluate their role in preventing such outcomes.

In 1988–1994, 24% of children aged 2–5 years had dental caries in their primary teeth. By 1999–2004, that rate had edged up to 28%, according to a report from the Centers for Disease Control and Prevention.

The population sample from the CDC's National Center for Health Statistics involved more than 52,000 participants, aged 2–75 years and older. All of the participants had oral health exams, and they or their parents, in the case of children, underwent home interviews. About half of the group was assessed during 1988–1994; the other half was assessed during 1999–2004.

“It's not a surprise at all,” that the dental decay rates are going up among the youngest age set, said Dr. Alan B. Douglass, associate director of the family practice residency program at Middlesex Hospital, in Middletown, Conn. Eighty percent of dental disease clusters in the 20% of children who are at high risk for the disease because they are from low-income families. “It's the access to care issue that's the driver. We are seeing more dental decay because these high-risk kids are having trouble getting access to care.”

In many states, Medicaid reimburses dentists less than the cost of delivering care, which tends to involve high overhead because of the instruments required, Dr. Douglass explained.

Through hearings, such as those in Congress earlier this month, and with several legislative efforts at the state level, advocates hope to achieve parity for dental care under Medicaid.

But until better access is achieved, “It's incumbent upon family physicians to get involved,” Dr. Douglass urged. “They and other primary pediatric care providers are the only medical professionals who are seeing kids when the disease starts,” which in many cases is as soon as teeth start to erupt at 6 to 9 months of age.

Dental disease already has set in by the time a child is 2 years old, by which point “family physicians and other primary pediatric providers have seen these kids at least 7 or 8 times,” noted Dr. Russell Maier, program director of Central Washington Family Medicine Residency in Yakima.

Primary care providers can't treat dental disease once it's there, but they can do a lot to prevent it. At each wellness visit, they need to look at a child's teeth and decide if the individual is in the at-risk group. If the parents' teeth are missing or if they've had a lot of restorative work, that should raise a red flag, Dr. Douglass said.

Primary care providers are critical in raising parental awareness about the importance of oral hygiene, diet, and eating patterns, he added.

Moreover, primary care providers are well placed to address the need for flouride and to advocate on behalf of a high-risk patient to ensure that he or she sees a dentist at age 1 year.

Dr. Douglass admits that, in many cases, such advocacy would require “working the system” to overcome poor access to care—there are only about 5,000 pediatric dentists in the United States—and the difficulties in finding a dentist willing to accept Medicaid patients. (See column above.)

Dental disease is the most common unmet pediatric health care need in this country, and yet at the same time “we know what causes it. We know what we need to do to arrest and prevent its complications,” Dr. Maier said.

A significant increase in the prevalence rates of dental caries in the primary teeth of children aged 2–5 years has experts urging primary care providers to reevaluate their role in preventing such outcomes.

In 1988–1994, 24% of children aged 2–5 years had dental caries in their primary teeth. By 1999–2004, that rate had edged up to 28%, according to a report from the Centers for Disease Control and Prevention.

The population sample from the CDC's National Center for Health Statistics involved more than 52,000 participants, aged 2–75 years and older. All of the participants had oral health exams, and they or their parents, in the case of children, underwent home interviews. About half of the group was assessed during 1988–1994; the other half was assessed during 1999–2004.

“It's not a surprise at all,” that the dental decay rates are going up among the youngest age set, said Dr. Alan B. Douglass, associate director of the family practice residency program at Middlesex Hospital, in Middletown, Conn. Eighty percent of dental disease clusters in the 20% of children who are at high risk for the disease because they are from low-income families. “It's the access to care issue that's the driver. We are seeing more dental decay because these high-risk kids are having trouble getting access to care.”

In many states, Medicaid reimburses dentists less than the cost of delivering care, which tends to involve high overhead because of the instruments required, Dr. Douglass explained.

Through hearings, such as those in Congress earlier this month, and with several legislative efforts at the state level, advocates hope to achieve parity for dental care under Medicaid.

But until better access is achieved, “It's incumbent upon family physicians to get involved,” Dr. Douglass urged. “They and other primary pediatric care providers are the only medical professionals who are seeing kids when the disease starts,” which in many cases is as soon as teeth start to erupt at 6 to 9 months of age.

Dental disease already has set in by the time a child is 2 years old, by which point “family physicians and other primary pediatric providers have seen these kids at least 7 or 8 times,” noted Dr. Russell Maier, program director of Central Washington Family Medicine Residency in Yakima.

Primary care providers can't treat dental disease once it's there, but they can do a lot to prevent it. At each wellness visit, they need to look at a child's teeth and decide if the individual is in the at-risk group. If the parents' teeth are missing or if they've had a lot of restorative work, that should raise a red flag, Dr. Douglass said.

Primary care providers are critical in raising parental awareness about the importance of oral hygiene, diet, and eating patterns, he added.

Moreover, primary care providers are well placed to address the need for flouride and to advocate on behalf of a high-risk patient to ensure that he or she sees a dentist at age 1 year.

Dr. Douglass admits that, in many cases, such advocacy would require “working the system” to overcome poor access to care—there are only about 5,000 pediatric dentists in the United States—and the difficulties in finding a dentist willing to accept Medicaid patients. (See column above.)

Dental disease is the most common unmet pediatric health care need in this country, and yet at the same time “we know what causes it. We know what we need to do to arrest and prevent its complications,” Dr. Maier said.

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Rituximab Combo Eases Neuropsychiatric SLE

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VIENNA – B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European Congress of Rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis with or without intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes on the objective parameters, Dr. Neuwelt measured patient outcomes using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy.

In her case, combination IV-CYC and rituximab led to significant improvements over baseline (See MRI images before and after combination therapy, at right).

Further research is needed to determine the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan).

However, he did not receive funding from Genentech for his study.

Outcomes from his observational study of 22 patients compared well with earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41).

Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients who were treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations.

Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS is the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life,” he said.

There are no exact end points with which to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE–specifically, ones targeting neuropsychiatric markers–need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist.

In MS, the importance of B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from a low of 37% to a high of 95% in various studies.

The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%-18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%) and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia.

A 45-year-old patient with severe CNS-NPSLE was switched from IV-CYC to rituximab monotherapy. A baseline brain MRI in April (left) showed progression of lesions. After a disease flare, IV-CYC was added. After the combination therapy, an MRI in July (right) showed a reduced number of lesions. Photos courtesy Dr. C. Michael Neuwelt

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VIENNA – B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European Congress of Rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis with or without intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes on the objective parameters, Dr. Neuwelt measured patient outcomes using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy.

In her case, combination IV-CYC and rituximab led to significant improvements over baseline (See MRI images before and after combination therapy, at right).

Further research is needed to determine the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan).

However, he did not receive funding from Genentech for his study.

Outcomes from his observational study of 22 patients compared well with earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41).

Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients who were treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations.

Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS is the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life,” he said.

There are no exact end points with which to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE–specifically, ones targeting neuropsychiatric markers–need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist.

In MS, the importance of B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from a low of 37% to a high of 95% in various studies.

The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%-18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%) and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia.

A 45-year-old patient with severe CNS-NPSLE was switched from IV-CYC to rituximab monotherapy. A baseline brain MRI in April (left) showed progression of lesions. After a disease flare, IV-CYC was added. After the combination therapy, an MRI in July (right) showed a reduced number of lesions. Photos courtesy Dr. C. Michael Neuwelt

VIENNA – B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European Congress of Rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis with or without intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes on the objective parameters, Dr. Neuwelt measured patient outcomes using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy.

In her case, combination IV-CYC and rituximab led to significant improvements over baseline (See MRI images before and after combination therapy, at right).

Further research is needed to determine the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan).

However, he did not receive funding from Genentech for his study.

Outcomes from his observational study of 22 patients compared well with earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41).

Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients who were treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations.

Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS is the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life,” he said.

There are no exact end points with which to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE–specifically, ones targeting neuropsychiatric markers–need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist.

In MS, the importance of B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from a low of 37% to a high of 95% in various studies.

The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%-18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%) and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia.

A 45-year-old patient with severe CNS-NPSLE was switched from IV-CYC to rituximab monotherapy. A baseline brain MRI in April (left) showed progression of lesions. After a disease flare, IV-CYC was added. After the combination therapy, an MRI in July (right) showed a reduced number of lesions. Photos courtesy Dr. C. Michael Neuwelt

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B-Cell Depletion Shows Promise in CNS-NPSLE

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B-Cell Depletion Shows Promise in CNS-NPSLE

VIENNA — B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European congress of rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis and/or intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes in the objective parameters, patient outcomes were measured using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy. In her case, combination IV-CYC and rituximab led to significant improvements over baseline (see MRI images before and after combination therapy).

Further research is needed to identify the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan). However, he did not receive funding for his study.

Outcomes from his observational study of 22 patients compared well to earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41). Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations. Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS effects are the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life, he said. There are no exact end points to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE—specifically, ones targeting neuropsychiatric markers—need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist. In MS, B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from 37% to 95% in various studies. The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%–18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%), and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia. Dr. Hanly also presented on CNS-NPSLE at the meeting.

A 45-year-old woman was switched from IV CYC to rituximab monotherapy. Shortly after the switch, the patient's disease flared and a brain MRI in April (left) showed progression of her lesions. IV CYC was then added back to her regimen. A follow-up MRI in July showed the number of lesions was reduced on the combination. Photos courtesy Dr. C. Michael Neuwelt

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VIENNA — B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European congress of rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis and/or intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes in the objective parameters, patient outcomes were measured using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy. In her case, combination IV-CYC and rituximab led to significant improvements over baseline (see MRI images before and after combination therapy).

Further research is needed to identify the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan). However, he did not receive funding for his study.

Outcomes from his observational study of 22 patients compared well to earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41). Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations. Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS effects are the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life, he said. There are no exact end points to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE—specifically, ones targeting neuropsychiatric markers—need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist. In MS, B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from 37% to 95% in various studies. The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%–18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%), and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia. Dr. Hanly also presented on CNS-NPSLE at the meeting.

A 45-year-old woman was switched from IV CYC to rituximab monotherapy. Shortly after the switch, the patient's disease flared and a brain MRI in April (left) showed progression of her lesions. IV CYC was then added back to her regimen. A follow-up MRI in July showed the number of lesions was reduced on the combination. Photos courtesy Dr. C. Michael Neuwelt

VIENNA — B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European congress of rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis and/or intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes in the objective parameters, patient outcomes were measured using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy. In her case, combination IV-CYC and rituximab led to significant improvements over baseline (see MRI images before and after combination therapy).

Further research is needed to identify the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan). However, he did not receive funding for his study.

Outcomes from his observational study of 22 patients compared well to earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41). Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations. Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS effects are the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life, he said. There are no exact end points to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE—specifically, ones targeting neuropsychiatric markers—need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist. In MS, B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from 37% to 95% in various studies. The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%–18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%), and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia. Dr. Hanly also presented on CNS-NPSLE at the meeting.

A 45-year-old woman was switched from IV CYC to rituximab monotherapy. Shortly after the switch, the patient's disease flared and a brain MRI in April (left) showed progression of her lesions. IV CYC was then added back to her regimen. A follow-up MRI in July showed the number of lesions was reduced on the combination. Photos courtesy Dr. C. Michael Neuwelt

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